TerminatedNCT03446040Updated Sep 18, 2025Results posted

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

A Phase 1/2 interventional study of BMS-986258 and Nivolumab in Advanced Cancer, sponsored by Bristol-Myers Squibb. Terminated at 16 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Bristol-Myers Squibb · Phase 1/2, Interventional, and Treatment

Why this study was terminated

Business objectives have changed

Phase: Phase 1/2
Study type: Interventional
Enrollment: 92
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

Conditions studied

Advanced Cancer

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies
Women must agree to follow specific methods of contraception, if applicable

Exclusion criteria

Exclusion Criteria:

Active, known or suspected autoimmune disease
Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria apply

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 92 participants (actual)

Study arms

Experimental
Part A Dose Escalation: BMS-986258
Biological: BMS-986258
Experimental
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Biological: BMS-986258 · Drug: rHuPH20
Experimental
Part B Dose Escalation: BMS-986258 + nivolumab
Biological: BMS-986258 · Biological: Nivolumab
Experimental
Part C Cohort Expansion: BMS-986258 + nivolumab
Biological: BMS-986258 · Biological: Nivolumab

Interventions

BiologicalBMS-986258
Specified dose on specified days
BiologicalNivolumab
Specified dose on specified days
Also known as: Opdivo, BMS-936558
DrugrHuPH20
Specified dose on specified days
Also known as: Enhanze

What researchers measure

Primary outcomes

Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Number of Participants Who Died During the Study
The number of participants who died during the study.
Time frame: From first dose until death due to any cause (up to approximately 78 months)
Number of Participants With Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.
Time frame: From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)

Secondary outcomes

Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)
Median Duration of Response (mDOR)
Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. Based on Kaplan-Meier estimates.
Time frame: From first dose until disease progression or death whichever occurred first (up to approximately 78 months)
Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months
Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Time frame: At 6, 9, and 12 months after first dose
Maximum Plasma Concentration (Cmax) of BMS-986258
Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.
Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258
AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time. It helps in understanding the overall amount of drug that has been in your body over that time period.
Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258
AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.
Time frame: Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Concentration at the End of the Dosing Interval (Ctau) of BMS-986258
Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.
Time frame: Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)
Time to Reach Maximum Concentration (Tmax) of BMS-986258
Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.
Time frame: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab
Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment
Time frame: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)

Results

Posted Sep 18, 2025

Participant flow

Participant flow — Overall Study
Milestone	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Started	3	3	4	4	4	9	3	5	8	4	11	4	15	15
Transitioned from part a1	0	0	0	0	0	0	0	0	0	0	0	2	2	0
Completed	0	0	0	0	0	0	0	0	4	0	1	0	8	6
Not completed	3	3	4	4	4	9	3	5	4	4	10	4	7	9
Withdrew: Disease progression	3	3	3	4	4	6	3	4	2	4	9	3	7	7
Withdrew: Study drug toxicity	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Withdrew: Adverse event	0	0	0	0	0	2	0	0	1	0	0	0	0	0
Withdrew: Death	0	0	0	0	0	0	0	0	0	0	1	0	0	2
Withdrew: Participant requested to discontinue study treatment	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Withdrew: Participant withdrew consent	0	0	0	0	0	1	0	1	0	0	0	0	0	0
Withdrew: Not reported	0	0	1	0	0	0	0	0	0	0	0	0	0	0

Outcome measures

PrimaryNumber of Participants With Adverse Events (AEs)

An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect.

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events (AEs)
Participants	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Adverse Events (AEs)	3	3	4	4	4	8	2	5	8	4	11	6	17	13
Serious Adverse Events (SAEs)	1	2	3	1	0	4	1	3	2	2	6	1	6	3
Adverse Events (AEs) leading to discontinuation of study treatment	0	0	1	1	0	2	0	0	0	0	0	0	3	0

PrimaryNumber of Participants Who Died During the Study

The number of participants who died during the study.

Time frame:: From first dose until death due to any cause (up to approximately 78 months)
Reported as:: Count of participants · Participants

Number of Participants Who Died During the Study
Participants	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Number of Participants Who Died During the Study	3	3	3	3	3	7	3	4	5	3	9	0	10	8

PrimaryNumber of Participants With Dose Limiting Toxicities (DLTs)

Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level.

Time frame:: From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28)
Reported as:: Count of participants · Participants

Number of Participants With Dose Limiting Toxicities (DLTs)
Participants	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Number of Participants With Dose Limiting Toxicities (DLTs)	0	0	0	0	0	0	0	0	0	0	0	0	0	0

SecondaryObjective Response Rate (ORR)

Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time frame:: From first dose until disease progression or death, whichever occurred first (up to approximately 78 months)
Reported as:: Number · Percent of Participants

Objective Response Rate (ORR)
Percent of Participants	Part A: All Doses	Part B: All Doses	Part A1: BMS-986258 1200 mg + ENHANZE
Objective Response Rate (ORR)	0 (0.00 to 8.22)	5.4 (0.66 to 18.19)	0 (0.00 to 21.80)

SecondaryMedian Duration of Response (mDOR)

Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. Based on Kaplan-Meier estimates.

Time frame:: From first dose until disease progression or death whichever occurred first (up to approximately 78 months)
Reported as:: Median · Months

Median Duration of Response (mDOR)
Months	Part A: All Doses	Part B: All Doses	Part A1: BMS-986258 1200 mg + ENHANZE
Median Duration of Response (mDOR)	—	NA (NA to NA)	—

SecondaryProgression-Free Survival (PFS) Rate at 6, 9, and 12 Months

Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.

Time frame:: At 6, 9, and 12 months after first dose
Reported as:: Number · Percent of Participants

Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months
Percent of Participants	Part A: All Doses	Part B: All Doses	Part A1: BMS-986258 1200 mg + ENHANZE
6-month	21.4 (9.3 to 36.8)	21.9 (8.4 to 39.3)	8.7 (0.5 to 32.0)
9-month	17.1 (6.2 to 32.6)	8.2 (0.8 to 27.7)	8.7 (0.5 to 32.0)
12-month	17.1 (6.2 to 32.6)	0.0 (NA to NA)	0.0 (NA to NA)

SecondaryMaximum Plasma Concentration (Cmax) of BMS-986258

Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be.

Time frame:: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Reported as:: Geometric mean · ug/mL

Maximum Plasma Concentration (Cmax) of BMS-986258
ug/mL	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Cycle 1 Day 1	2.27 ± 53.8	5.34 ± 36.2	31.5 ± 10.9	47.2 ± 120	121 ± 30.7	239 ± 35.6	423 ± 12.9	412 ± 26.7	890 ± 29.2	154 ± 43.4	244 ± 24.8	449 ± 31.5	579 ± 19.4	121 ± 44.1
Cycle 3 Day 1	—	9.26 ± NA	—	50 ± NA	—	356 ± NA	—	—	605 ± NA	111 ± NA	161 ± NA	422 ± NA	684 ± 18.1	—
Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	479 ± 21.2

SecondaryArea Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258

AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time. It helps in understanding the overall amount of drug that has been in your body over that time period.

Time frame:: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Reported as:: Geometric mean · h*ug/mL

Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258
h*ug/mL	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Cycle 1 Day 1	53.7 ± 50.8	457 ± 56	4690 ± 43.3	8180 ± 101	26100 ± 46.7	46000 ± 83.9	97000 ± 23.3	75300 ± 44.5	179000 ± 24.3	29000 ± 51.4	44300 ± 34.9	84100 ± 83.2	118000 ± 25.4	48500 ± 51.1
Cycle 3 Day 1	—	1400 ± NA	—	13400 ± NA	—	102000 ± NA	—	—	135000 ± NA	29800 ± NA	38200 ± NA	89000 ± NA	171000 ± 27	—
Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	138000 ± 21

SecondaryArea Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258

AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule.

Time frame:: Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Reported as:: Geometric mean · h*ug/mL

Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258
h*ug/mL	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Cycle 1 Day 1	—	587 ± 41.9	4870 ± 43.7	8400 ± 105	26900 ± 47.4	56400 ± 45	100000 ± 18	85800 ± 21.9	187000 ± 29.5	29000 ± 51.4	47300 ± 29.4	89600 ± 67.9	120000 ± 22.5	46200 ± 53.9
Cycle 3 Day 1	—	1440 ± NA	—	13400 ± NA	—	102000 ± NA	—	—	135000 ± NA	18600 ± NA	38200 ± NA	89000 ± NA	172000 ± 26.1	—
Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	134000 ± 17.3

SecondaryConcentration at the End of the Dosing Interval (Ctau) of BMS-986258

Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low.

Time frame:: Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks)
Reported as:: Geometric mean · ug/mL

Concentration at the End of the Dosing Interval (Ctau) of BMS-986258
ug/mL	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Cycle 1 Day 29 predose	—	0.0245 ± 52.3	1.58 ± 116	2.59 ± 369	15.5 ± 68.6	37.2 ± 62.9	55.7 ± 55.2	36.9 ± 68.5	109 ± 44.6	15.6 ± 82.3	23.5 ± 70.3	39.8 ± 229	68.4 ± 47.1	37.7 ± 80.2
Cycle 3 Day 29 predose	—	0.0711 ± NA	—	8.32 ± NA	—	80.3 ± NA	—	—	71.3 ± NA	7.77 ± NA	25 ± NA	37.1 ± NA	121 ± 36.6	—
Cycle 2 Day 1 predose	—	—	—	—	—	—	—	—	—	—	—	—	—	114 ± 13

SecondaryTime to Reach Maximum Concentration (Tmax) of BMS-986258

Tmax (Time to Reach Maximum Concentration) is the time it takes for the drug to reach its highest level in the blood after taking it. It helps in understanding how quickly the drug starts to work and reaches its peak effect.

Time frame:: Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks)
Reported as:: Geometric mean · Hours

Time to Reach Maximum Concentration (Tmax) of BMS-986258
Hours	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE
Cycle 1 Day 1	0.808 (0.033 to 4)	1.23 (0.117 to 4)	1.4 (0.45 to 4)	2.11 (0.45 to 24.5)	3.92 (0.617 to 24)	0.998 (0.467 to 4.13)	1.09 (0.467 to 4.38)	1.47 (1.47 to 1.48)	3.11 (2 to 4.05)	0.812 (0.467 to 4)	4.18 (4 to 4.58)	1.02 (0.983 to 1.07)	2.29 (1.47 to 5.52)	123 (72.2 to 168)
Cycle 3 Day 1	—	4 (4 to 4)	—	0.7 (0.7 to 0.7)	—	4.27 (4 to 4.55)	—	—	2 (2 to 2)	0.499 (0.467 to 0.533)	0.467 (0.467 to 0.467)	2.02 (1.02 to 4)	2.74 (1.47 to 5.48)	—
Cycle 1 Day 29	—	—	—	—	—	—	—	—	—	—	—	—	—	1.26 (0.967 to 2.33)

SecondaryNumber of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab

Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment

Time frame:: From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks)
Reported as:: Count of participants · Participants

Number of Participants With Anti-Drug Antibodies to BMS-986258 or Nivolumab
Participants	Part A: All Doses	Part B: All Doses
Baseline ADA positive: BMS-986258	0	0
ADA positive: BMS-986258	2	0
Baseline ADA positive: nivolumab	—	1
ADA positive: nivolumab	—	2

Adverse events

Collected over All-cause mortality (ACM) was assessed from first dose until death due to any cause (up to approximately 78 months). Serious-adverse events (AEs) and Other adverse events (AEs) were assessed from first dose until 100 days after last dose of study therapy (up to approximately 78 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part A: BMS-986258 8 mg	3/3 (100%)	1/3 (33.3%)	2/3 (66.7%)
Part A: BMS-986258 24 mg	3/3 (100%)	2/3 (66.7%)	2/3 (66.7%)
Part A: BMS-986258 72 mg	3/4 (75%)	3/4 (75%)	4/4 (100%)
Part A: BMS-986258 200 mg	3/4 (75%)	1/4 (25%)	4/4 (100%)
Part A: BMS-986258 480 mg	3/4 (75%)	0/4 (0%)	4/4 (100%)
Part A: BMS-986258 800 mg	7/9 (77.8%)	4/9 (44.4%)	8/9 (88.9%)
Part A: BMS-986258 1200 mg	3/3 (100%)	1/3 (33.3%)	2/3 (66.7%)
Part A: BMS-986258 1600 mg	4/5 (80%)	3/5 (60%)	5/5 (100%)
Part A: BMS-986258 2400 mg	5/8 (62.5%)	2/8 (25%)	8/8 (100%)
Part B: BMS-986258 480 mg + NIVO 480 mg	3/4 (75%)	2/4 (50%)	4/4 (100%)
Part B: BMS-986258 800 mg + NIVO 480 mg	9/11 (81.8%)	6/11 (54.5%)	9/11 (81.8%)
Part B: BMS-986258 1200 mg + NIVO 480 mg	0/4 (0%)	1/4 (25%)	4/4 (100%)
Part B: BMS-986258 1600 mg + NIVO 480 mg	10/15 (66.7%)	6/15 (40%)	15/15 (100%)
Part A1: BMS-986258 1200 mg + ENHANZE	7/11 (63.6%)	3/11 (27.3%)	9/11 (81.8%)
Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo	1/2 (50%)	0/2 (0%)	2/2 (100%)
Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo	0/2 (0%)	0/2 (0%)	2/2 (100%)

Most frequent serious events

Showing 10 of 35

Most frequent serious events
Event	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo	Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/3	1/3	2/4	1/4	0/4	3/9	0/3	1/5	1/8	1/4	1/11	0/4	2/15	2/11	0/2	0/2
Small intestinal obstructionGastrointestinal disorders	0/3	1/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
General physical health deteriorationGeneral disorders	1/3	0/3	1/4	0/4	0/4	1/9	1/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
DyspnoeaRespiratory, thoracic and mediastinal disorders	1/3	0/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
Abdominal painGastrointestinal disorders	0/3	0/3	1/4	0/4	0/4	0/9	0/3	1/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
SepsisInfections and infestations	0/3	0/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	1/4	1/15	0/11	0/2	0/2
DehydrationMetabolism and nutrition disorders	0/3	0/3	1/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
Confusional statePsychiatric disorders	0/3	0/3	0/4	1/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2
HaematuriaRenal and urinary disorders	0/3	0/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	1/4	0/11	0/4	0/15	0/11	0/2	0/2
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders	0/3	0/3	1/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	0/2	0/2

Most frequent other events

Showing 10 of 146

Most frequent other events
Event	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Part A1 Crossover to Part B: 1200 mg BMS + 480 mg Nivo	Part A1 Crossover to Part B: 1600 mg BMS + 480 mg Nivo
AnaemiaBlood and lymphatic system disorders	1/3	0/3	1/4	1/4	0/4	0/9	0/3	0/5	2/8	0/4	0/11	1/4	1/15	0/11	0/2	2/2
NauseaGastrointestinal disorders	0/3	1/3	2/4	1/4	1/4	0/9	1/3	2/5	2/8	0/4	4/11	1/4	2/15	1/11	2/2	2/2
FatigueGeneral disorders	1/3	1/3	3/4	1/4	2/4	4/9	1/3	1/5	3/8	1/4	6/11	0/4	4/15	3/11	0/2	0/2
Abdominal painGastrointestinal disorders	0/3	2/3	2/4	1/4	1/4	0/9	0/3	0/5	2/8	0/4	0/11	1/4	0/15	1/11	0/2	1/2
DiarrhoeaGastrointestinal disorders	0/3	2/3	1/4	0/4	1/4	0/9	0/3	1/5	1/8	2/4	3/11	1/4	2/15	1/11	0/2	1/2
VomitingGastrointestinal disorders	0/3	1/3	0/4	1/4	1/4	0/9	2/3	1/5	3/8	0/4	1/11	0/4	0/15	1/11	1/2	0/2
CoughRespiratory, thoracic and mediastinal disorders	0/3	0/3	0/4	0/4	0/4	1/9	2/3	2/5	0/8	0/4	1/11	0/4	2/15	1/11	0/2	0/2
Decreased appetiteMetabolism and nutrition disorders	0/3	0/3	2/4	2/4	1/4	2/9	1/3	2/5	5/8	0/4	3/11	1/4	2/15	1/11	1/2	1/2
NeutropeniaBlood and lymphatic system disorders	0/3	0/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	0/4	0/11	0/4	0/15	0/11	1/2	0/2
HypothyroidismEndocrine disorders	0/3	0/3	0/4	0/4	0/4	0/9	0/3	0/5	0/8	1/4	0/11	0/4	0/15	0/11	1/2	0/2

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Total
Mean	60.7 ± 16.17	45.7 ± 6.03	61.5 ± 3.11	67.0 ± 4.24	60 ± 12.44	61.1 ± 7.10	65.3 ± 8.33	54.8 ± 8.07	58.4 ± 5.85	64.5 ± 5.07	62.5 ± 7.75	57.3 ± 16.2	58.5 ± 15.0	57.8 ± 12.27	59.6 ± 10.62

Sex: Female, Male
Sex: Female, Male(Participants)	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Total
Female	1	0	4	3	1	4	3	1	2	2	3	2	5	4	35
Male	2	3	0	1	3	5	0	4	6	2	8	2	10	11	57

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Total
Hispanic or Latino	1	0	0	0	1	0	0	0	0	0	0	0	1	1	4
Not Hispanic or Latino	2	3	4	4	3	8	3	5	8	3	10	4	11	14	82
Unknown or Not Reported	0	0	0	0	0	1	0	0	0	1	1	0	3	0	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part A: BMS-986258 8 mg	Part A: BMS-986258 24 mg	Part A: BMS-986258 72 mg	Part A: BMS-986258 200 mg	Part A: BMS-986258 480 mg	Part A: BMS-986258 800 mg	Part A: BMS-986258 1200 mg	Part A: BMS-986258 1600 mg	Part A: BMS-986258 2400 mg	Part B: BMS-986258 480 mg + NIVO 480 mg	Part B: BMS-986258 800 mg + NIVO 480 mg	Part B: BMS-986258 1200 mg + NIVO 480 mg	Part B: BMS-986258 1600 mg + NIVO 480 mg	Part A1: BMS-986258 1200 mg + ENHANZE	Total
American Indian or Alaska Native	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1
Asian	0	0	1	1	2	1	1	1	3	1	2	2	4	3	22
Native Hawaiian or Other Pacific Islander	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1
Black or African American	0	1	1	1	0	1	0	2	0	0	0	0	1	2	9
White	2	0	2	2	2	7	2	2	5	3	8	2	8	10	55
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	0	0	0	0	0	0	0	0	1	0	2	0	4

Study locations

16 sites

Local Institution - 0004
Los Angeles, California 90033, United States
Local Institution - 0006
Los Angeles, California 90033, United States
Local Institution - 0007
Aurora, Colorado 80045, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242, United States
Local Institution - 0018
Ann Arbor, Michigan 48109-5912, United States
Local Institution - 0010
Grand Rapids, Michigan 49546, United States
Local Institution - 0012
Lebanon, New Hampshire 03756, United States
Local Institution - 0016
Cincinnati, Ohio 45267, United States
Local Institution - 0005
Pittsburgh, Pennsylvania 15232, United States
Local Institution - 0002
Germantown, Tennessee 38138, United States
Local Institution - 0013
Westmead, New South Wales 2145, Australia
Local Institution - 0015
Melbourne, Victoria 3084, Australia
Local Institution - 0014
Edmonton, Alberta T6X 1E8, Canada
Local Institution - 0019
Vancouver, British Columbia V5Z 4E6, Canada
Local Institution - 0009
Kobe, Hyōgo 6500017, Japan
Local Institution - 0008
Chuo-ku, Tokyo 1040045, Japan

References and documents

Publications

El Halabi L, Adam J, Gravelle P, Marty V, Danu A, Lazarovici J, Ribrag V, Bosq J, Camara-Clayette V, Laurent C, Ghez D. Expression of the Immune Checkpoint Regulators LAG-3 and TIM-3 in Classical Hodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):257-266.e3. doi: 10.1016/j.clml.2020.11.009. Epub 2020 Nov 12. PubMed 33277223 ↗

Study documents

Protocol and statistical analysis plan · Jun 16, 2021

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03446040
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Feb 26, 2018
Start date: Mar 8, 2018
Primary completion: Aug 29, 2024
Completion: Aug 29, 2024
Results posted: Sep 18, 2025
Last update: Sep 18, 2025

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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